1. Field of the Invention
The present invention relates to a device and a method for locating and marking the optimum position of the centre of a hole for receiving a stoma in stomal hernia support garment, especially stomal hernia support trousers and a set for use for locating and marking the optimum position of the centre of a hole for receiving a stoma in stomal hernia support garment.
In connection with surgery for a number of diseases in the gastrointestinal tract a consequence is, in many cases, that the colon, the ileum or the urethra has been exposed surgically and the patient is left with an abdominal stoma. Such artificial openings or fistulae cannot be controlled at will and are therefore of necessity incontinent and the effluents or waste products of the body, which are conveyed through these organs, are discharged through the artificial orifice or opening and are collected in a collection bag. Said bag which is usually adhered to the skin by means of an adhesive wafer or plate having an inlet opening for accommodating the stoma. Such appliances may be two-piece or one-piece appliances. In both types of appliances, a body side member is attached to the wearer's abdomen, and a receiving member or bag is attached to the body side ostomy member for receiving exudates from the stoma. Said receiving in case of a two-piece appliance.
In many instances patients having had a surgery resulting in the formation of a stoma, an accompanying condition is formation of a peristomal bulge or hernia, which may complicate the bandaging of the stoma and even require further surgery. Even if further surgery is carried out there is a considerable risk of a permanent condition, which cannot be alleviated.
In such cases, the patient will have to rely on an additional hernia support for a mechanical reposition of the bulge or hernia for reducing the risk of constriction or strangulation calling for urgent surgery and for providing a plane surface around the stoma for application of a collecting appliance in order to secure a proper adherence and sealing. Stomal bulge or hernia supports are commonly known and may e.g. be in the form of a belt of e.g. of leather with buckles or in the form of a support garment made from an elastic fabric being able to apply a sufficient pressure around the stoma.
In the case of a colostomy and in case the ostomate is normally irrigating, a minor cap or collecting bag may be used which enables the use of a firm support belt or tight compression briefs for providing a sufficient pressure around the stoma. For ileostomates or urostomates this procedure is not practicable due to the constant rather high output from the ileum or bladder and for urostomates it may be critical to provide a free flow from the stoma in order to prevent a build-up of a backpressure, which may destroy the kidneys.
In such cases, it is highly desirable or mandatory to give access to a larger collecting volume, which means that the collecting bag itself will have to be situated outside the pressure establishing belt or briefs and that a passageway through the same has to be established.
Determination of the site for placing the stoma is normally carried out prior to the operation after observing the patient in different postures, e.g. sitting, standing and bending over, finding the less critical area. WO 00/67683 discloses a device for use in the determination of the optimum position of a stoma-to-be for the patient in question.
As the placing of a stoma is not standardised but depends on the condition and the topography of the abdominal area of the patient, it is not possible to provide a simple selection of standard bulge or hernia supports having passageways fitting the majority of patients. The passageways must be precisely tailored according to the actual conditions of the individual patient.
2. Description of the Related Art
DK Patent Application No. PA 1999 01559 discloses a stomal hernial support compression garment in the form of a pair of customised compression trousers. The trousers are tailored by determining the dimensions of the patient and the localisation of the stoma for producing a pair of trousers specifically for the patient in question for ensuring a specific compression force. The manufacture of such a hernial support is laborious and expensive as the whole support is made specifically for each patient.
U.S. Pat. No. 5,135,520 discloses a variable closure device for an ostomy garment having a pair of criss-cross pocket forming panels configures to lie behind an ostomy device. The crisscross arrangement of pocket panels are created by finished edges which overlap along their lower ends to define an adjustable, elongated, slanted slot.
No devices for an easy location and marking of a hole for receiving a stoma for tailoring a hernia support from a standard support garment is disclosed and there is a need for such device in order to enable a simple, convenient, and cheap tailoring of hernia supports for improving the security against leakage and the quality of life for the patient after this kind of surgery.
The present invention provides a simple device and method for an easy determination and marking of the site for a customised hole in a standard support garment for enabling a free flow of effluents from a stoma to pass the hernia trousers without compromising the hernia supporting properties thereof. The invention also offers a simple, convenient, and reliable method for a decentralised collection of the necessary information and simple transfer thereof to the manufacturer for a centralised manufacture of customised support garments.